GUEST COLUMNISTS

• Complete Response Letters For CGTs Share This Common Theme

  One expert’s analysis found CMC-related concerns in about 75% of complete response letters. He outlines a path to stronger CMC readiness for cell and gene therapies.

• Your 7 Decisions To Make Before MES Configuration

  Don't wait until manufacturing execution system (MES) configuration to answer these 7 questions. Define your manufacturing process before digitizing it.

• The Orange Book's Blind Spot: Process Stability And Capability

  The current system for assuring therapeutic equivalence contains structural blind spots. Companies must evolve rather than merely adding corrective actions.

• Are You Falling Behind On Intelligent Pharmaceutical Manufacturing?

  With a focus on small molecule drug product manufacture, let's take a closer look at the efficiencies gained through closed-loop control, PAT, digital twins, and more.

• DEA Reveals Hidden Costs Of Analytical Validation Guidelines

  By treating distinct validation guidelines as decision-making units, data envelopment analysis (DEA) allows for the mathematical evaluation of their resource efficiency.

• Qualification And Validation Of Depyrogenation Tunnels And Autoclaves

  Systemic vulnerabilities exist in thermal uniformity assurance, steam penetration verification, regulatory fragmentation, and tech harmonization. 

• FDA Modernizes Container Closure Guidance: What Is Changing And Why It Matters

  The proposed revision reflects changes in packaging technology, drug delivery systems, quality risk management, and more that have occurred since 1999's guidance.

• CDMO Selection Beyond Capabilities And Price

  Some of the most useful information relevant to CDMO selection is also the hardest to obtain. Here are suggestions for uncovering data that tells the whole capability story.